An interventional study of ARC-IM Investigational System implantation in Spinal Cord Injuries, sponsored by Ecole Polytechnique Fédérale de Lausanne. Recruiting at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-30.
Sponsored by Ecole Polytechnique Fédérale de Lausanne · Not applicable, Interventional, and Treatment
The HemON study aims to evaluate the safety and preliminary efficacy of ARC-IM Therapy (Epidural Electrical Stimulation) to improve hemodynamic management and trunk control in people with sub-acute or chronic spinal cord injury (>= 1 month post injury) between C3 and T6 inclusive, who suffer from orthostatic hypotension.
1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.
This study's planned enrollment of 20 is below the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →Ecole Polytechnique Fédérale de Lausanne is the lead sponsor of 20 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All participants will be provided with the ARC-IM Investigational System (implantable and non-implantable parts)
Device: ARC-IM Investigational System implantation
Implantation of a stimulation lead on the low thoracic level of the spinal cord and implantation of a neurostimulator in the abdominal region.
Occurrence of Serious Adverse Events and Adverse Events that are deemed related or possibly related to the study procedure or to the ARC-IM Investigational System
Evaluate the safety of ARC-IM Therapy at supporting management of hemodynamic instability in participants with sub-acute or chronic spinal cord injury suffering from orthostatic hypotension
Time frame: Throughout study, an average of 26 months
Orthostatic head-up tilt test (hemodynamic stability assessment)
Participant begin by resting in the supine position during which baseline measures are performed. Thereafter, participant is passively moved to upright position using a tilt-table and kept in this position for a maximum of 10 minutes. This test will be performed with and without ARC-IM Therapy. Beat by beat blood pressure is monitored and catecholamine concentrations in the plasma are measured during the tilt-test.
Time frame: Baseline ; at 1 - 6.5 - 13 - 26 months after the implantation
Modified Ashworth Scale (MAS) (spasticity assessment)
Participants' upper and lower limb spasticity levels (6 points nominal scale) are assessed by rating the resistance of a muscle to a passive range of motion about a single joint. This test will be performed with and without ARC-IM Therapy. Scores range from 0 to 5 (0, 1, 1+, 2, 3, 4, 5) with higher scores indicating higher spasticity.
Time frame: Baseline ; at 1 - 13 months after the implantation
SCIM III (daily life performance assessment)
The Spinal Cord Independence Measure (SCIM) is a disability score to assess functional activity in participants. Function is assessed in 3 areas of function: self-care (0-20), respiration and sphincter management (0-40) and mobility (0-40). Total score ranges between 0-100, with higher scores reflecting greater functional ability
Time frame: Baseline ; at 1 - 6.5 - 13 months after the implantation
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Ecole Polytechnique Fédérale de Lausanne